Marketed in 33 countries across Europe and parts of Latin America, Prandin is an internationally distributed brand of repaglinide, classified as a hypoglycemic agent used in the management of diabetes. The footprint puts the brand in front of travellers and expatriates moving between European Union member states, Nordic markets, and several markets further afield.
Repaglinide is prescribed in the management of type 2 diabetes mellitus, generally as part of a broader treatment plan that may include lifestyle measures and other glucose-lowering therapies. The structured indication block further down this page lists the registered uses recognised by the national regulators in each market where Prandin is sold, and the precise wording of those indications can vary slightly from country to country.
Because Prandin circulates so widely, travellers and expatriates often encounter repaglinide abroad — sometimes under the Prandin label, sometimes under a different brand or as a generic. Markets where the brand is registered include Brazil, Germany, Finland, Greece, and Hungary, but national packaging, prescription pathways, and even the brand name on the box can differ. A local pharmacist is usually the right first point of contact for confirming whether a product on a foreign shelf is the same medication.
Other glucose-lowering medications used in type 2 diabetes are sold in many of the same markets under different molecules and different brand names, and they are not freely interchangeable — the choice of agent depends on the individual clinical picture. For anyone managing diabetes across borders, decisions about starting, stopping, or substituting any glucose-lowering medication belong with a healthcare provider familiar with the patient's history, ideally supported by a pharmacist who knows the local formulary.
5 years.
Not applicable.
Microcrystalline cellulose (E460)
Calcium hydrogen phosphate, anhydrous
Maize starch
Polacrilin potassium
Povidone (polyvidone)
Glycerol 85%
Magnesium stearate
Meglumine
Poloxamer
Iron oxide, yellow (1 mg tablets only) (E172)
Iron oxide, red (2 mg tablets only) (E172)
Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Repaglinide was shown not to be teratogenic in animal studies. Embryotoxicity, abnormal limb development in rat foetuses and new born pups, was observed in female rats exposed to high doses in the last stage of pregnancy and during the lactation period. Repaglinide was detected in the milk of animals.
Absorption
Repaglinide is rapidly absorbed from the gastrointestinal tract, which leads to a rapid increase in the plasma concentration of the active substance. The peak plasma level occurs within one hour post administration. After reaching a maximum, the plasma level decreases rapidly.
Repaglinide pharmacokinetics are characterised by a mean absolute bioavailability of 63% (CV 11%).
No clinically relevant differences were seen in the pharmacokinetics of repaglinide, when repaglinide was administered 0, 15 or 30 minutes before a meal or in fasting state.
A high interindividual variability (60%) in repaglinide plasma concentrations has been detected in the clinical trials. Intraindividual variability is low to moderate (35%) and as repaglinide should be titrated against the clinical response, efficacy is not affected by interindividual variability.
Distribution
Repaglinide pharmacokinetics are characterised by low volume of distribution, 30 L (consistent with distribution into intracellular fluid) and is highly bound to plasma proteins in humans (greater than 98%).
Elimination
Repaglinide is eliminated rapidly within 4 - 6 hours from the blood. The plasma elimination half-life is approximately one hour.
Repaglinide is almost completely metabolised, and no metabolites with clinically relevant hypoglycaemic effect have been identified.
Repaglinide metabolites are excreted primarily via the bile. A small fraction (less than 8%) of the administered dose appears in the urine, primarily as metabolites. Less than 1% of repaglinide is recovered in faeces.
Special patient groups
Repaglinide exposure is increased in patients with hepatic insufficiency and in the elderly type 2 diabetic patients. The AUC (SD) after 2 mg single dose exposure (4 mg in patients with hepatic insufficiency) was 31.4 ng/ml x hr (28.3) in healthy volunteers, 304.9 ng/ml x hr (228.0) in patients with hepatic insufficiency, and 117.9 ng/ml x hr (83.8) in the elderly type 2 diabetic patients.
After a 5 day treatment of repaglinide (2 mg x 3/day) in patients with a severe impaired renal function (creatinine clearance: 20-39 ml/min.), the results showed a significant 2-fold increase of the exposure (AUC) and half-life (t1/2) as compared to patients with normal renal function.
Paediatric population
No data are available.
05/2016
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark
Store in the original package in order to protect from moisture.
The blister pack (aluminium/aluminium) contains 30, 90, 120 or 270 tablets, respectively.
Not all pack sizes may be marketed.
Prandin 0.5 mg | EU/1/00/162/003-005, EU/1/00/162/021 |
Prandin 1 mg | EU/1/00/162/009-011, EU/1/00/162/020 |
Prandin 2 mg | EU/1/00/162/015-017, EU/1/00/162/019 |
No special requirements.
Date of first authorisation: 29 January 2001
Date of last renewal: 23 July 2008
Prandin is prescribed in the management of type 2 diabetes mellitus. The active ingredient belongs to the broader category of glucose-lowering medications used in diabetes care, and is typically used as part of a wider treatment plan that may include dietary measures and other therapies. The structured indication block below this introduction lists the specific registered uses recognised by national regulators in the markets where Prandin is sold.
Prandin contains repaglinide, classified as a hypoglycemic agent used in diabetes care. Repaglinide is the same molecule whether sold under the Prandin label or as a generic — internationally, the same active ingredient circulates under several commercial names, particularly in markets where multiple manufacturers produce repaglinide-containing products in parallel after patent expiry.
Prandin is registered in 33 countries, with a footprint concentrated across Europe and extending to several markets beyond. Examples include Brazil, Germany, Finland, Hungary, Ireland, and the Czech Republic. If your country is not represented in this list, a local pharmacist can usually confirm whether repaglinide is sold in that market under a different brand name or as a generic.
Repaglinide is sold under several brand names worldwide in markets where the patent has expired. Other glucose-lowering medications used in type 2 diabetes also exist across multiple pharmacological categories, although they are not interchangeable without medical guidance — the choice of agent depends on the individual clinical picture. To identify a local repaglinide-containing product, search the active ingredient on Pill2Trip or ask a pharmacist in your country.
Prandin is a prescription medication in the markets where it is sold, and diabetes therapy in particular is calibrated to a patient's overall metabolic profile, concurrent medications, and individual circumstances. This matters especially for travellers and people relocating between countries, since prescription rules, brand names, and available generics differ across regulatory regimes. Any decision to start, stop, or substitute repaglinide should be led by a healthcare provider familiar with the patient.
